BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS DREAMSTATION

    MDR report key: 12307625 · Received August 10, 2021

    Report

    Report Number
    MW5103160
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    May 26, 2021
    Report Date
    August 8, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE (B)(6) 2021, I HAD HEADACHES ALMOST DAILY. I BEGAN TO NOTICE BY MID (B)(6) THAT DAYS WHEN I DIDN'T USE THE CPAP MACHINE, MY HEADACHES WERE NON EXISTENT. I NOTICED THE LENGTH OF USE EACH NIGHT WAS DIRECTED RELATED TO THE SEVERITY OF THE HEADACHE THE NEXT DAY. I ALSO EXPERIENCED SEVERAL ISSUES IF FUNNY FEELINGS IN MY CHEST. IT WASN'T REALLY PRESSURE AND IT WAS HARD TO DESCRIBE. SEVERAL HEART TEST WERE DONE AND NOTHING WAS FOUND. THE FIRST MONTH OFF THE MACHINE I HAD NO HEADACHES. I AM NOW EXPERIENCING THEM SOME DAYS EVEN WITHOUT USING THE MACHINE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197884 RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability